AU773608B2 - Sanitary napkin and method for collecting samples of bodily substances - Google Patents

Description

P/00/011 28/5/91 Regulaton 3.2(2)

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION STANDARD PATENT Application Number: Lodged: Invention Title: SANITARY NAPKIN AND METHOD FOR COLLECTING SAMPLES OF BODILY SUBSTANCES The following statement is a full description of this invention, including the best method of performing it known to us Sanitary Napkin And Method For Collecting Samples Of Bodily Substances Technical Field The present invention relates to collection devices for recovering samples of bodily fluids or cells for subsequent laboratory analysis and, more particularly, to a collection device and method for allowing the patient to recover samples of bodily fluids, secretions, cells, and infectious and non-infectious agents, in whole all hereinafter referred to as bodily substances, and, for instance, to a sampling strip for use with a sanitary napkin for collecting such substances from the genital, anal or urinary regions, and to a method associated with the use thereof.

Background Art United States Patent No. 5,231,992 issued on August 3, 1993 to Leon discloses a low-impact cervical cell and fluid collector which includes a substantially disc-shaped main body 12 which defines a generally concave recess 14 into which a porous collection membrane 16 is mounted. Therefore, when the collector 10 is in place adjacent to the patient's cervix, cells and fluids Sadhere to the outer surface of the membrane 16. Underneath the membrane 16, there is provided a layer 24 of a cell-moistening material or agent, such as a polymer gel adapted to release water during cell collection for moistening IIII1: S collected cells through the pores of the membrane 16 when the cells are adhered to the outer surface thereof. The main body 12 can be provided with a string 18 S-to facilitate the removal of the collector 10 from the body.

French Patent Application which was published as FR-2 599 500 on December 4, 1987 in the name of Chieusse discloses a transparent adhesive strip for taking a sample directly from the skin's surface for microscopic examination or analysis, the adhesive strip comprising a rigid transparent resin or glass plate 1 covered successively with a transparent layer 2 which is selfadhesive on both of its sides, an isolating film or coating 4 of shorter length, and a semi-rigid cover layer 3 made, for instance, of strong paper or cardboard. The limited length of the film 4 defines a section 5 where the cover layer 3 adheres directly to the adhesive 2 and forms a joint line 6 which allows for the cover layer 3 to be pivotally lifted about the hinge 6, wherein in a closed position 7, the sample-taking surface 9 is protected for its transport or storage, whereas in its open position 8, the adhesive surface 2 can be brought into direct contact with the skin's surface such as to enable the adhesive strip 2 to remove and collect desired samples from the skin and other surfaces for subsequent analysis thereof.

United States Re-Issue Patent No. RE 24,666 issued on July 7, 1959 to Draghi discloses a tampon for the detection of cancer of the pelvic region. More particularly, the tampon of this U.S. Patent constitutes a preliminary diagnosis method which determines if there are present any indicia of cancer by taking a sample of cells which are present in the cervical canal and in the vagina and by the subsequent microscopic analysis of these cells. The tampon includes a o 0i tampon body 10 partly covered by a jacket 12 terminating with an enlarged cap 13 and, at the other end of the tampon body 10, there is provided a string 22.

The assembly of the body 10 and jacket 12 forms a detection tampon 14. The enlarged cap 13 which closes one end of the tampon 14 is adapted to extend Sfarthest into the vaginal canal and to collect and retain in moist form cells thereof.

The jacket 12 also collects cells and retains them in a relatively moist condition thereby ensuring a more accurate clinical evaluation.

United States Patent No. 3,850,160 issued on November. 26, 1974 to Denson discloses a diagnostic tampon 10 having a supporting body 13 covered by an outer film 12 and provided at one end thereof with a removal string 11. The tampon is particularly adapted for collecting cellular material from body cavities, S in particular from the vaginal cavity, for subsequent examination.

United States Patent No. 5,432,097 issued on July 11, 1995 to Yourno teaches a method for the recovery of blood cells from dried blood spots on a filter paper.

United States Patent No. 5,119,828 issued on June 9, 1992 to Miller discloses a device 10 for collecting sebum which is secreted by the sebaceous glands of a patient, the device 10 including a microporous film 12 which is opaque to light when the pores are filled with gaseous material and which is substantially translucent when the film pores are filled with sebum. The film 12 is mounted to a substrate 14 which defines a light absorbing area 16 for enhancing visualization of the pores of the film 12 when filled with sebum. In use, the device is pressed against the patient's skin surface such that the film 12 contacts the f I I 3 skin and absorbs its sebum, whereby a sebum spot pattern is developed in the film 12 and is visually enhanced by way of the light absorbing area 16.

United States Patent No. 5,088,502 issued on February 18, 1992 to Miller discloses a device 10 for sampling the surface of the skin which includes a substrate 12 having a light absorbing area 14 disposed thereon with an adhesive layer 16 being disposed on the substrate 12 such as to overlie the light absorbing area 14. The adhesive layer 16 is optically clear and under pressure conforms to the surface of the skin to be sampled. A removable protective film 18 provided with a tab 20 is disposed on the adhesive layer 16 for protecting the same prior to 10 use of the device. The device and, more particularly, the adhesive layer 16 is placed against the skin surface such that, when removed, skin cells adhere to the adhesive layer 16. The sampled cells can then be visualized in view of the light S absorbing area 14.

United States Patent No. 4,789,629 issued on December 6, 1988 to Baker et al teaches a device for collecting and testing fecal occult blood which includes a pocket-like member 16 and an absorbent insert 24 disposed in the pocket member 16. The pocket member 16 is disposed on the inside front cover of the device such that when the cover is in a closed position thereof, the pocket 16 overlies the fecal smear on the specimen receiving sheet 36, whereby with one single collection, two separate membranes, that is the specimen receiving sheet and the absorbent insert 24, receive the components of the fecal sample and can be individually and independently tested.

United States Patent No. 4,808,379 issued on February 28, 1989 to Wardlaw et al discloses a device for obtaining stool samples and detecting occult blood and which is used in a way similar to toilet tissue to obtain a stool sample on a receptor sheet 26 provided in the device. Therefore, to obtain the stool sample, the patient, after defecation, draws the cover sheet 32 and its holes 34 across the rectum in the same manner as toilet tissue such that stool is thus wiped onto the cover sheet and passes through the openings 34 and deposits in spots on the receptor sheet 26. The cover sheet 32 is then peeled off and discarded, thereby exposing the stool spots S of the receptor sheet 26, after which the stool spots S can be effectively sealed in the device by folding the impermeable sheet 2.

14- 4-04; 3;58PM;Watermark 14-4-0; 35SP;Waermrk;61893254463 6/ 4 DISCLOSURE OF THE INVENTION It is therefore an aim of the present invention to provide an improved device for allowing a patient to collect externally from the body samples of bodily substances, such as fluids, cells, tissues, microorganisms, etc.

It is a further preferred aim of the present invention to provide a modified sanitary napkin for collecting samples of bodily substances from the genital, anal or urinary regions and, for instance, vaginal secretions.

It is a still further preferred aim of the present invention to provide a modified sanitary napkin provided with an absorbent layer for collecting the samples of bodily substances from the genital, anal or urinary regions.

In accordance with the present invention, there is provided a collection device for collecting bodily substances from the genital, anal or urinary regions, including a substantially flexible and comfortable member adapted to be positioned such that a receiving surface of said member is located substantially opposite a location from which a sample of at [east one predetermined bodily substance forming part of a group of bodily substances Is to be taken, a sampling filter being provided in communication with said receiving surface, said sampling filter being capable of selectively retaining at least part of said at least one predetermined bodily substance for subsequent analysis thereof while allowing fluid substances to pass therethrough.

BRIEF DESCRIPTION OF THE DRAWINGS Having thus generally described the nature of the invention, referenoe will now be made to the accompanying drawings, showing by way of illustration a preferred embodiment thereof, and in which: 25 Fig. 1 is a perspective view of a modified sanitary napkin in accordance with the present invention; Fig. 2 is a perspective view of the sanitary napkin of Fig. 1 but illustrated with its removable absorbent sampling strip partly removed therefrom; Fig. 3 is a transversal cross-sectional view taken along line 3-3 of Fig. 2; Fig. 4 is a longitudinal cross-sectional view taken along line 4-4 of Fig. 1; and COMS ID Na:SMBI-00706826 Received by IF' Australia: Time 18:09 Date 2004-04-14 14- 4-04; 3:58PM;Watermark ;61893254463 7/ Fig. 5 is schematic perspective view of a variant of a collecting device also in accordance with the present invention which is shown in a partly detached position.

MODES FOR CARRYING OUT THE INVENTION The present invention is concerned with the collection of samples of bodily substances (such as fluids, secretions, cells, microorganisms, infectious and noninfectious agents, etc.) and, more particularly, in view of some people's reticence 1: 25 >o oo o *oo oo *o o* o* *ooo 2 3* oI COMS ID No: SMBI-00706826 Received by IP Australia: Time 18:09 Date 2004-04-14 14- 4-04; 3:58PM;,Watermark ;19246 /2 -161893254463 8/ p p p.

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COMS ID No: SMBI-00706826 Received by IP Australia: Time 18:09 Date 2004-04-14 in having these samples taken at a clinic or-hospital, with a collection device and method which allow the patient to "self-collect" the samples, typically outside of any formal medical environment, which can then be properly packaged and forwarded for subsequent analysis thereof to any appropriate medical facility, e.g.

laboratory.

In the present description as well as in the appended claims, the terms "substance" and "substances" are understood to include any bodily fluids, secretions, cells, microorganisms, infectious and non-infectious agents, etc., which can be externally recovered from the body.

S. 10 For instance, and in accordance with the present invention, Fig. 1 illustrates a modified sanitary napkin N which is intended for collecting substances at the genital and anal regions and which includes a porous outer sleeve 10 having upper and lower sheets 12 and 14, respectively, which are joined at a first longitudinal end 16 thereof and which are open at an opposite second longitudinal end 18 of the sleeve 10. The upper and lower sheets 12 and *14 are at least partly made of a porous fabric, typically in the form of a close knit netting. Inside the sleeve 10, there is provided an absorbent layer 20, of the type well known in the art of sanitary napkins. The absorbent layer 20 is peripherally secured to the upper and lower sheets 12 and 14 of the porous sleeve 10, apart from at the second end 18 where the absorbent layer 20 is typically only secured to the lower sheet 14 such that the opening at the second end 18 is defined between the upper sheet 12 and the absorbent layer 20, as best seen in Fig. 4.

Under or outwardly of the lower sheet 14, an insulating or impermeable layer 22 acting as a liquid impervious barrier is mounted to the lower sheet 14 and is provided with an adhesive coating on a side of the impermeable layer 22 opposite its side secured to the lower sheet 14 of the sleeve 10. A removable strip 24 is detachably mounted to the adhesive coating of the impermeable layer 22 such that it can be removed therefrom when the sanitary napkin N is to be attached to an undergarment.

Intermediate the upper sheet 12 of the sleeve 10 and the absorbent layer a removable absorbent sampling filter or strip 26 is slidably received in a pocket 28 which is defined between the upper sheet 12 and the absorbent layer and which is open at the second end 18, again as best seen in Fig. 4. The

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8 sampling strip 26 is provided at an outside end thereof with a handling tab The sampling strip 26 can be made, for instance, of a semi-porous and absorbent material, e.g. a sheet-like filter made of paper, of synthetic or non-synthetic fabrics, etc., such as to allow the patient to collect substances, for instance vaginal secretions, as samples for subsequent analysis thereof in a laboratory or the like while allowing for excess secretions and fluids to pass therethrough and reach the absorbent layer 20 and to be collected thereon.

In the present embodiment of the invention which takes the form of the sanitary napkin N, the description might refer to vaginal secretions instead of the 10 more general "substances" mentioned hereinabove, but this is only done for illustration purposes, that is as an example of a use of the present sanitary napkin N and is obviously not intended to restrict the scope of use of any collection device in accordance with the present invention to the single collection of vaginal secretion samples.

More particularly, in use, the sanitary napkin N has the form generally .shown in Fig. 1 with its removable strip 24 being removed therefrom such as to allow the sanitary napkin N to be attached to an undergarment. Subsequently, vaginal secretions, for example, will come into contact with the sanitary napkin N and, more particularly, with the upper sheet 12 of the sleeve 10 thereof. Through the netting of the upper sheet 12, the vaginal secretions will then reach the sampling strip 26, whereat some of the secretions will be absorbed and retained by the sampling strip 26 with the remainder of the secretions filtering therethrough and reaching the absorbent layer 20. Therefore, a sampling of vaginal secretions will have collected on the sampling strip 26 which, before the sanitary napkin N is discarded, is removed from the sanitary napkin N as per arrow 32 of Fig. 2, whereby the sampling strip 26 can then be properly packaged and sent, for instance, to a laboratory to be analyzed. Therefore, the sanitary napkin N of the present invention which is intended to facilitate and render more accessible the uncovering, for example, of sexually transmitted diseases by reducing some people's resistance to showing up at clinics to be tested by way of the collection of samples for analysis purposes, is considered to meet this object as, clearly, the simple use in a typically well-known fashion of a substantially recognizable sanitary napkin N will allow for a proper 9 -sampling of bodily substances, such as vaginal secretions, to be easily obtained and forwarded to a laboratory, using the present absorbent sampling strip or filter 26 as a collection medium which is typically sealed in an appropriate container once it has been removed from the sanitary napkin N, and until it is ready to be analyzed in the laboratory.

In the laboratory, the sampling filter 26 can be analyzed by way of known techniques, such as polymerase chain reaction (PCR) and ligase chain reaction (LCR) techniques, etc.

Accordingly, the present sanitary napkin N which is based on modifications S made to conventional sanitary napkins can be easily used by the patient as a collection and reception medium for various substances secretions) provided externally of the genital, anal or urinary regions, from which a sample can then be obtained by removing the sampling strip 26 from the sanitary napkin

N.

The present invention also contemplates having a non-removable, i.e. at the level of the end user, sampling filter or strip or collector installed in the sanitary napkin, whereby the complete sanitary napkin would be sent to the 09: laboratory, whereat it would be appropriately dismantled to retrieve its sampling 0.00 strip for the analysis thereof.

Furthermore, by the present invention, there is also provided a method of collecting samples of bodily substances, such as of secretions emitted at the genital, anal or urinary regions, by providing a collection medium which is adapted to be positioned at an appropriate location, for instance in the undergarment, and externally of the user, and which is further adapted to receive and/or collect samples of bodily substances, the samples being then typically properly packaged for the subsequent analysis thereof.

The present collection device, which has been herein preferably shown and described in the form of the sanitary napkin N for collecting vaginal secretions, as well as the present collection method can obviously be also used to collect various other bodily substances, such as biological fluids, blood, tissues, microorganisms or cells (again all herein generally referred to as substances), for instance, from the genito-urinary tract or system and/or from the anal region.

Accordingly; various applications of the collection device are foreseen, such as for the analysis of products accumulated in the sampling filter or strip 26, including research on and identification of infectious agents chlamydia, HIV, gonorrhea, herpes, cytomegalovirus, human papillomavirus, mycoplasma, ureaplasma, candida and other infectious and non-infectious agents, etc.) or parasites trichomonas) or any other biochemical particle or component originating from these agents with a view of identifying and treating these agents by known techniques as well as by techniques which will be developed; for the analysis of cells from the genito-urinary or intestinal system for the 10 chromosomal, histological, cytological, biochemical or biomolecular analysis thereof; for the analysis of the menstrual blood, or its derivatives (e.g.

antibodies) and of any other molecule detected in the sampling strip 26; for the analysis of urine, of its derivatives and of any other molecule originating from the urinary system and detected in the sampling strip 26; and for the analysis of products derived from the pilosebaceous system of the genital, anal and cutaneous sphere; etc.

With reference to Fig. 5 which illustrates a variant of the present invention, the sampling strip can alternatively take the form of a stand-alone collecting device D which is adapted to be used externally of a sanitary napkin (not illustrated), including conventional sanitary napkins. More particularly, the collecting device D comprises a sampling strip 50 made of a suitable absorbent material, a ring-shaped adhesive border or layer 52 provided peripherally on the underside of the absorbent sampling strip 50, and a removable backing sheet 54.

The sampling strip 50 resembles in function the sampling strip 26 of Figs.

1 to 4 but is intended to be affixed on the outside of a sanitary napkin, typically by the end user; this is achieved by peeling off the backing sheet 54 from the adhesive layer 52 of the sampling strip 50 and by then securing the latter to the sanitary napkin by way of the adhesive layer 52 with the sampling strip 50 being positioned on the sanitary napkin such as to collect substances discharged by the body. The sampling strip 50 can then be separated from the sanitary napkin and sent for analysis; alternatively, the sanitary napkin with the sampling strip attached thereto can be forwarded for analysis.

14- 4-04; 3;58PM;Watermark 14-4-0; 35SP;Waermr61893254463 G/ Both the sampling strips 26 and 50 must be made of a suitable material, typically absorbent and flexible and, at least in the case of the sampling strip of a smooth and comfortable material. Various materials could be used, including fabrics or paper or nylon-based materials. For instance, the sampling strip may be of any woven, non woven or knitted materials perious to body fluids. and having the capacity to absorb or adsorb the biological materials required for analysis by mechanical retention or chemical interaction. The sampling strip can be positively charged and may have ion-exchange properties. Also, the sampling strip may be composed of cationjo, positively charged, fibers. Further, the sampling strip may be composed of fibers which are finished with positively charged monomer(s) and/or polymer(s).

Basically, the invention is intended to enable the patient to recover samples of secretions, fluids, etc. emitted from the body, as well as samples of cells, fluids, etc. which are present at the cutaneous level for the collection of 15 substances from sores, etc., such as in the case of some types of herpetic infections which manifest on the skin) and to sealingly package the collected samples which can then be forwarded to a laboratory for the analysis thereof.

Comprises/comprising and grammatical variations thereof when used in this specification are to be taken to specify the presence of stated features, integers, steps or components or groups thereof, but do not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

0' COMS ID No: SMBI-00706826 Received by IP Australia: Time (Htm) 18:09 Date 2004-04-14

Claims (1)

14- 4-04; 3:56PM;Watermark 14-4-0; 358P;Wagrmrk;61893254463 10/ 12 THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS: 1. A collection device for collecting bodily substances from the genital, anal or urinary regions, including a substantially flexible and comfortable member adapted to be positioned such that a receiving surface of said member is located substantially opposite a location from which a sample of at least one predetermined bodily substance forming part of a group of bodily substances is to be taken, a sampling Jilter being provided in communication with said receiving surface, said sampling filter being capable of selectively retaining at least part of said at least one predetermined bodily substance for subsequent analysis thereof while allowing fluid substances to pass therethrough. A collection device according to claim 1, wherein said collection device *includes attachment means adapted to secure said collection device to a sanitary napkin. 3. A collection device as defined in Claim 2, wherein said attachment means 15 includes adhesive means provided on an underside of said collection device, removable backing means being provided on said adhesive means prior to said collection device being attached to the sanitary napkin. A collection device as defined in any one of claims 1 to 3, wherein said sampling filter is made of any woven, non woven or knitted materials pervious to 20 body fluids and having the capacity to absorb or adsorb the biological materials required for analysis. A collection device as defined in Claim 4, wherein said sampling filter is positively charged and has ion-exchange properties. 6. A collection device as defined in Claim 4, wherein said sampling filter is composed of cationic, positively charged, fibers. COMS IDNo: SMBI-00706826 Received by IP Australia: Time 18:09 Date 2004-04-14 14- 4-04; 3;58PM,;Watermark689243 hI0 ;61893254463 i 1/ 13 7. A collection device as defined in Claim 4, wherein said sampling filter is composed of fibers which are finished with positively charged monomer(s) and/or polymer(s). DATED this 14th day of April 2004 EZYDETEK (EDI) INC. WATERMARK PATENT TRADE MARK ATTORNEYS 290 BURWOOD ROAD HAWTHORN VICTORIA 3122 AUSTRALIA PNF/SWE *0 0 0 0 0000 0*.0 0 0 0 0 I I COMS ID No: SMBI-00706826 Received by IP Australia: Time 18:09 Date 2004-04-14